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KONICA MINOLTA HEALTHCARE DO BRA

⚠️ Moderate Risk

FEI: 3026586774 • Nova Lima, Minas Gerais • BRAZIL

FEI

FEI Number

3026586774

📍

Location

Nova Lima, Minas Gerais

🇧🇷

Country

BRAZIL
🏢

Address

Rua Star, 420, , Nova Lima, Minas Gerais, Brazil

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
4/14/2023
Latest Refusal
4/14/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
44.5×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
4/14/2023
90KPRSYSTEM, X-RAY, STATIONARY
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is KONICA MINOLTA HEALTHCARE DO BRA's FDA import refusal history?

KONICA MINOLTA HEALTHCARE DO BRA (FEI: 3026586774) has 1 FDA import refusal record(s) in our database, spanning from 4/14/2023 to 4/14/2023.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. KONICA MINOLTA HEALTHCARE DO BRA's FEI number is 3026586774.

What types of violations has KONICA MINOLTA HEALTHCARE DO BRA received?

KONICA MINOLTA HEALTHCARE DO BRA has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about KONICA MINOLTA HEALTHCARE DO BRA come from?

All FDA import refusal data for KONICA MINOLTA HEALTHCARE DO BRA is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.